Determining whether you are a candidate for adult stem cell therapy is a highly individualized process for each patient at Okyanos. This therapy can be appropriate for a variety of chronic diseases, many of which have few or no acceptable, FDA-approved treatment options. We encourage you to speak to a Patient Liaison regarding the specifics of your medical condition. Our medical team will then carefully review your medical history to determine whether or not Okyanos Cell Therapy is right for you.
A great deal of independent research shows evidence that stem cells decrease inflammation and increase small blood vessel growth in the heart. Experience from research trials show improvement in:
- Exercise tolerance
- Shortness of breath
- Chest pains (angina)
Each patient case is analyzed individually, and the benefits will range from patient to patient. Cardiac stem cell therapy will not cure you of heart disease but, according to research, should improve your symptoms and quality of life.
For example, if you’re a walker, like to play with your children or would like to simply make it up the stairs without being out of breath—this procedure should help you towards these goals. Data from the clinical trial known as PRECISE showed marked improvements in quality of life measures in treated patients after 90 days.
The procedure consists of several parts, all of which all of which is completed in a full day, including observation and recovery time. Read a more in-depth overview of the Okyanos Cell Therapy procedure steps here.
The stem and regenerative cells stored in your body fat could be likened to small “physicians” who diagnose and correct individual areas of the body in need of special attention. Because these cells have the capacity to detect changes in the body which are causing pain or dysfunction, they respond and communicate with the body’s needs to provide the correct tools needed for healing. These adult stem cells are commonly referred to as “repair cells,” their primary functions being:
- Accelerated tissue repair
- Stimulated tissue regeneration
- Decreased inflammation
- Prevention of continued premature cell death
- Creation of new blood vessels
Re-introducing your own stem cells into an injured area of the body—be it a joint, damaged heart or other tissue—can stimulate new blood flow in these areas while reducing inflammation. Cell therapy enables the stem cells in your body to do their job as tiny little “physicians” in the process of healing. Learn more about the potential benefits of cell therapy for chronic conditions here.
Depending on your individualized treatment plan, one of our licensed and trained interventional cardiologists, board certified general surgeons and cell therapy experts will perform your cell therapy procedure. Working alongside these doctors is our Clinical Administrator, Gretchen Dezelick and our team of nurses and medical technicians. Learn more about our world-class team here.
The risks are minimal. The Okyanos Cell Therapy protocols are based on rigorously conducted clinical trials wherein the implantation of adult stem cells produced little risk. There have been zero reports of cell-related adverse events.
We will deliver stem and regenerative cells derived from your own fat tissue, systemically by IV or directly into your heart or other injured area of the body. Because these cells are your own, the risk of cell rejection is eliminated. For cardiac patients, the risk of bleeding is very low and the procedure is similar to having an angioplasty.
Patients should be healthy enough to travel to the Bahamas and able to make it through the stem cell treatment without oxygen or respiratory issues during our 4-5 day program. Patients with diabetes or COPD can be considered for candidacy. We encourage all prospective patients to discuss their medical history with our doctors and nursing staff so we can determine whether our treatment is appropriate for you. We will also speak with your primary physician or cardiologist if you wish.
The FDA regulates, among other things, what drugs, biologics and devices can be marketed in the United States. The cell processing technologies used at Okyanos are internationally approved in Singapore, Australia, New Zealand, Japan and throughout Europe, and has been shown to have an excellent safety profile. The FDA can be, on average, about 5 years behind the EU in approving devices.
Most of us have at least some excess fat on our bodies, and now it just might prove to be useful. Using state-of-the-art technology, our doctors obtain stem cells from your body fat (or adipose tissue). We are able to extract this fat, isolate the stem cells and deliver them to the area of the body in need of special attention.
Stem cell extraction from the bone marrow is much more painful and can take weeks to process. Adipose stem cells are more abundant and are much more quickly obtained and processed to a therapeutic dose.
Okyanos practitioners use a minimally traumatic water-assisted fat harvesting technology. The unique blend of stem and regenerative cells which exist in the adipose tissue are then isolated and prepared for intravenous delivery utilizing an EU-approved, closed/sterile, fully automated CGMP cell processing system. For patients receiving direct injections, a closed/sterile, manually operated cell processing technology will be used to obtain a micro-fragmented, cell-rich product for injection.
A minimal amount of fat is required to carry out adult stem cell therapy. The fat is obtained from areas of excess in the abdomen or hips, and you will be able to discuss this further with the doctor. Due to the possibility of needing to place you on blood thinners during the implantation portion of the procedure, the doctor may prefer to take as small amount of adipose tissue as possible to obtain the amount of adult stem cells needed.
No, we use adult regenerative cells derived from your own body fat.
Not at this time. Until FDA approval, reimbursement in the US is unlikely.
Re-treatment is an option that could provide additional benefit and which would be discussed with the Okyanos medical team.
There have been over 50 cardiac cell therapy trials that have collectively treated approximately 2000 patients with coronary artery disease. The clinical trial known as PRECISE, upon which the Okyanos cardiac treatment protocol is based, was a rigorous double-blind placebo-controlled trial using adipose-derived stem and regenerative cells (ADRCs). This experimental research showed improvements in heart function and a reduction in the size of the infarct (wound) from the previous heart attack with a high degree of safety.
In addition, there have been thousands of clinical studies conducted which evaluate the safety and efficacy of using adipose stem cells to treat a variety of unmet healthcare needs, orthopedic problems, autoimmune diseases and neurodegenerative conditions.
We ask that you call and provide us with information about your specific condition so that we may advise you on pricing. Although cost is an important factor, it isn’t the only factor. Allow us to learn about you so we can determine if our treatment is right for you.
We can refer you to several financing sources that may work for you. Please visit our Financing page to learn more.
The fat harvesting procedure will be performed under IV sedation, and you will have the opportunity to meet with the anesthesiologist prior to your procedure to ensure any additional questions you have regarding the anesthetic are addressed.
While in the cath lab receiving the stem cell implantation portion of the procedure, only a light to moderate sedation is required. Both fat harvesting and cardiac cell implantation require numbing the areas with a local anesthesia like the Lidocaine you would receive during a dentist visit.
Most artificial heart valves are not a problem, but each patient’s case will be reviewed carefully by our cardiology team. The presence of a pacemaker or an implanted defibrillator poses no problem, but we will likely need to know the make and model number of these devices.
It is much easier on the patient to obtain stem cells from fat tissue than bone marrow. Through a very low-risk modified liposuction procedure, we isolate your stem cells from the extracted fat and prepare them for reintroduction back into your body.
Over the past decade or so, scientists have uncovered the wide potential of the adult stem cells found in our fat or adipose tissue, including a specific stem cell type called mesenchymal stem cells. Interestingly, fat tissue appears to contain thousands of times more stem cells than bone marrow.
These stem cells can help stimulate the growth of new blood vessels, reduce inflammation and help prevent further cell death—all functions very relevant to the treatment of diseased heart muscle.
No, we use autologous (from self) adult stem cells derived from your own body fat. These cells are known to be safe, abundant and potent as well as easily accessible. There is also no risk of rejection using your own stem cells.